Oferta pracy

Senior Specialist Regulatory Affairs



Powstańców Śląskich 95



Your responsibilities

Position Description

This is a temporary position for 2 years contract.

* Prepare, compile and complete submissions to global regulatory entities for QIAGEN’s In vitro Diagnostic products.

* Ensure compliance to the EU Medical Device Directive/in vitro Diagnostic Directive in Europe for QIAGEN products.

* Compile and review Technical Files.

* Maintain regulatory documentation for QIAGEN products as part of the Technical documentation.

* Participate in internal and external audits from global agencies.

* Maintain current knowledge base of existing and emerging global regulations to assist in future product development.

* Obtain and distribute updated information regarding international laws, guidelines, or standards.

* Develop regulatory infrastructure and documentation templates to support global submissions.

* Write or update regulatory standard operating procedures, work instructions, or policies.

* Support internal stakeholders with product registrations and maintenance activities, customer enquiries and provision of regulated documents as required.

* May be responsible for supervising up to two employees.

* May perform other duties as required or assigned.

Our requirements

  • MS in Biotechnology or related field.

  • Minimum 4 years of relevant work experience.

  • Minimum 2 years’ experience with global regulatory submissions in the In vitro diagnostic industry.

  • Fluency in English.

  • Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices,

  • preferably for In vitro Diagnostic Systems.

  • Working knowledge of European and International IVD regulations.

  • Proficient use of Microsoft Office products suite and experience with SAP, MasterControl and

  • Trackwise.

  • Prior experience in handling global regulatory projects.

  • Experience working effectively in a cross-functional team setting.

  • Experience working with global multi-lingual teams

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

We offer:

- Possibility to develop in an international company

- Training and development programs

- Private medical care

- Group Life Insurance

- Multisport card

- Flexible benefits platform

- Language classes

- Pension Scheme (PPE) after 12 months

- Childcare subsidy

- Happy Monday :)

- Friendly atmosphere

- Casual dress code

- Attractive location (Sky Tower)

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

  • Benefits

  • private medical care

  • sharing the costs of foreign language classes

  • sharing the costs of professional training & courses

  • life insurance

  • integration events

  • retirement pension plan

  • no dress code

  • coffee / tea

  • drinks

  • extra social benefits

  • employee referral program

  • charity initiatives


At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.

Our most valuable asset are our employees – more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.

There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.

If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every da

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